The efficacy of Saraswatham choornam as an add-on to Cognitive behavioural therapy in improving the symptoms of Generalized anxiety disorder- A randomized clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- • Changes in the anxiety scoring of Hamilton Anxiety Rating Scale.
研究概览
简要总结
Generalized anxiety disorder is characterized by persistent uncontrolled worry for more than 6 months about everyday things which could be multifocal and presented with many psychological and physical symptoms. Cognitive behavioural therapy and medications are the two main treatments. In this study, 40 subjects aged 20 to 50 years diagnosed with ICD 10 Criteria are divided into two groups of 20 participants each. Both groups are provided with 5 sessions of Cognitive behavioural therapy. One group will be given Ayurvedic medicine Saraswatham choornam 4gm with 8 gm of ghrutha and 4gm of madhu BD after food. The allocation will be concealed using the snooze technique. Outcome will be collected using a direct personal interview method and will be assessed by Hamilton anxiety rating scale and Manasabhava scale. Statistically tested using parametric and non-parametric tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically diagnosed cases of Generalized Anxiety Disorder based on ICD10 Criteria 2.20- 50 age group irrespective of gender, caste, religion and economic status.
- •3.Diagnosis should be confirmed by a specialist in Manasikaroga Vijnana.
排除标准
- •• Patients with psychiatric disorder & other systemic and metabolic disorders • Drug abuse and withdrawal patient.
- •• Pregnant women, Lactating women.
- •• Participants having completed any other trial within 6 months.
- •• Patients taking allopathic medications for GAD.
结局指标
主要结局
• Changes in the anxiety scoring of Hamilton Anxiety Rating Scale.
时间窗: At 0th, 28th and 35th day
• Changes in manasabhava scale score
时间窗: At 0th, 28th and 35th day
次要结局
- Changes in manasabhava scale score(On 1st, 28th and 35 th day)
研究者
Dr Shifana P M
Vaidyaratnam Ayurveda College Thaikkattussery, Ollur
